According to a company press release, Episurf Medical has given FDA 510(k), clearance to its Episealer patellofemoral implant system. This system is for patients with osteoarthritis that affects the distal patellofemoral joints.
According to the release, the Episealer system is designed to replace both the patellofemoral and the patellofemoral joints. It can treat focal lesions within the cartilage as well as overt OA.
“Gaining access to the U.S. market symbolizes a significant step for any orthopedic implant manufacturer,” Pål Ryfors, CEO of Episurf Medical, said in the release. “For Episurf, this clearance
